The Trump-RFK. Jr. HHS has never been known for its stability, competence, or commitment to protecting public health. But it’s been an especially dizzying week of chaos amid the FDA’s unprecedented wave of resignations, including top drug regulator Rick Pazdur, who’s resigning just weeks after taking the job over concerns about the “legality of” the agency’s “new drug review program.” The instability has alarmed former FDA commissioners, industry leaders, and public health experts who warn that the agency’s instability threatens drug development, food and vaccine safety, and public confidence. The Trump administration’s incompetence and focus on giving credence to junk science and anti-vax conspiracies have only left the nation less healthy and less prepared to deal with the next health crisis. A week in review:
- Politico: The FDA’s top drug regulator submits his resignation to the agency: Rick Pazdur, the FDA’s top drug regulator, told staff Tuesday he submitted his resignation to the agency, an abrupt departure weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval, according to four people familiar with the decision granted anonymity to discuss the move. […] The FDA’s drug center historically has seen little turnover among senior leadership, but it’s had four different leaders this year. The pending exit of Dr. Richard Pazdur, a veteran researcher who pioneered the FDA’s approach to cancer treatments, has caused the most concern, sources say. Pazdur plans to retire this month just weeks after accepting a role heading the FDA’s largest division overseeing prescription drugs, over-the-counter medicines and pharmacy staples.
- Washington Post: FDA instability, alarm over agency’s direction escalate after top regulator exits: In the last week, the leadership turnover and public concern about the direction of the agency charged with overseeing the safety of vaccines, medications and most of the U.S. food supply has only grown. […] The ongoing exits, negative headlines and other shake-ups at FDA have increasingly alarmed some drug-industry executives, public health experts and medical professionals who warn that it has left the agency increasingly fragile and threatens its mission. The drug industry relies on a predictable FDA to understand what it needs to do to win approval of new treatments, and executives fear instability at the agency could stymie advancements.
- New York Magazine’s Intelligencer: Doughnuts and Bullets The agony and absurdity of working for RFK Jr.: In September, there were reports of C. auris in Kansas, but the Agency’s contract with the C. auris expert had expired. There was an outbreak of botulism in infant formula, and in another era the Agency’s scientists would have been on television issuing warnings, but they were not allowed to interact directly with the media. There was an HIV outbreak in Maine, and the state asked for a team, but no team was sent. Staff were ordered to change all references of mpox to monkeypox, and no one could come up with any real justification for this beyond forcing them to do something they considered racist. […] In October, some 1,300 more people were terminated, but then around 700 were told their termination had been a coding error and invited back to work.
- Axios: FDA reaches “tipping point” after high-level departures: Twelve former FDA commissioners from Republican and Democratic administrations took the highly unusual step of publicly airing their concerns [last] Wednesday, writing in the New England Journal of Medicine that the upheaval “could diminish both the FDA’s strength and Americans’ health and safety.” The persistent complaint from former FDA officials and industry leaders is that political appointees are shutting out career agency scientists from decision-making, and that the departure of many agency veterans will jeopardize the drug review process.
- Axios: Kennedy gets personally involved in FDA personnel drama: Kennedy’s direct involvement signals the seriousness with which HHS is taking FDA’s personnel chaos. Pazdur has filed papers to retire from the agency at the end of this month. STAT reported that Pazdur was concerned about the legality of a new drug review program and Makary and other officials’ interference in drug review decisions and hiring.
- Washington Post: Under RFK Jr., the CDC provides a megaphone to the anti-vaccine movement: Such moments at the two-day meeting of the Advisory Committee on Immunization Practices (ACIP) prompted incredulity from some vaccine experts, medical associations and Democratic elected officials. […] Medical experts who watched the presentations during Thursday’s and Friday’s sessions said they were often incoherent, relying on technical language and data taken out of context or overblown. […] During the meetings, committee members and presenters made at least 60 false, misleading or unsupported claims about vaccine safety, disease spread and rationale for childhood vaccination, according to the Evidence Collective, a coalition of science and medicine researchers.
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